SOFIA ANALYZER AND INFLUENZA A+B FIA


Device Classification Name

antigens, cf (including cf control), influenza virus a, b, c

510(k) Number K112177
Device Name SOFIA ANALYZER AND INFLUENZA A+B FIA
Applicant
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

Applicant Contact john d tamerius
Correspondent
QUIDEL CORP.
10165 mckellar ct.
san diego, 
CA 
92121

Correspodent Contact john d tamerius
Regulation Number 866.3330
Classification Product Code
GNX  
Subsequent Product Code
KHO  
Date Received 07/28/2011
Decision Date 10/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls